New NGS DNA testing methods will replace PCR, predicts Clear Labs
Are ‘GMO-free’ (as opposed to ‘non-GMO’) claims legally defensible?
Clear Labs co-founder and chief marketing officer Mahni Ghorashi was speaking to FoodNavigator-USA as President Obama signed a federal GMO labeling bill that will require most packaged foods to carry a text label, symbol or electronic code readable by smartphone that indicates the presence of genetically modified organisms (GMOs).
Tests developed by Clear Labs – which was founded by software engineers, big-data analytics experts and genomics specialists in 2014 and has raised more than $8m – are based on a proprietary next-generation [genomic] sequencing (NGS) platform, and are more affordable and more powerful than traditional polymerase chain reaction (PCR) tests, in that they can identify “all of the most common types of GMOs on the market in a single test,” claimed Ghorashi.
“We believe using our technology it would be legally defensible to make GMO-free claims today, although new gene-editing techniques will pose a challenge in future [see below]. We have a broadscreen test that covers about 85% of known GMOs and then we have a deep screen, which can identify 100% of the known GMOs for any particular crop."
NGS testing: Faster, cheaper, more scalable
He added: “We’re seeing a huge surge in demand for GMO testing. Uunlike PCR-based tests, which narrowly target an individual gene or a subset of genes and can cost $150-$275, per test, per sample, NGS-based testing returns holistic views of each sample so we do not have to know what we are searching for ahead of time.
"In other words we don’t have to know what we are looking for, for the test to find it. And the cost of sequencing and the turnaround time is falling all the time.
“With PCR it’s too expensive to test for all potential GMOs in a sample, so manufacturers typically just test for one or two of the most common GMOs. The same applies when you are testing for contaminants in herbal supplements, for example. To date, no testing has been able to cover the whole final product, and test it comprehensively for adulteration. But we can do this.”
In my view, NGS is going to replace PCR
Similarly, if you are focused on food safety, and you're testing for the common strains of e.coli (0157) in taco meat with traditional testing methods, he said, you could miss rarer strains of e-coli (0152) if you are not specifically looking for them.
“In my view, NGS is going to become the dominant mode of food safety testing, whether from us or other players. It’s going to replace PCR. The power of NGS is that we can see everything in a sample, as opposed to traditional testing methods that are narrowly targeted.”
What does the new federal GMO labeling law say about non-GMO claims?
According to the new federal GMO labeling bill just signed into law by President Obama, organic certified products will be allowed to use the term ‘non-GMO.’
However, products that don't meet the 'bio-engineered' definition in the bill will not automatically be allowed to be labeled as non-GMO if they are not organic, says the bill (details of which will be clarified over the next two years by USDA, the implementing agency).
“A food may not be considered to be ‘not bioengineered,’ ‘non-GMO’ or any other similar claim describing the absence of bioengineering in the food solely because the food is not required to bear a disclosure that the food is bioengineered under this subtitle.”
Just because product doesn't meet bill's definition of 'bioengineered' doesn't automatically make it 'non-GMO'
A spokeswoman for the Senate Agriculture Committee told FoodNavigator-USA: "The language says you can’t be considered 'non-GMO' SOLELY because the food isn’t required to make a [GMO] disclosure under the national bioengineered food disclosure standard... [Manufacturers] just can’t say 'because it’s not subject to the new standard, the product is non-GMO.'"
Martin J Hahn, a partner at law firm Hogan Lovells, told us in June: "In many ways the provision captures the practices that exist today. Many foods would have fallen outside of the Vermont definition of genetically engineered foods but would not have qualified for the standards created by the Non-GMO Project or the NSF True North standards, for example."
Heat and processing can degrade DNA, but you can still identify it
But at what points in the supply chain should testing occur, and are tests on finished products, especially things like highly refined vegetable oils or sweeteners, likely to generate misleading results, because DNA can be degraded by heat and processing?
According to Ghorashi: “We work with retailers that want to do spot checks and audits of finished products as well as manufacturers that want to test ingredients, although the majority of the testing is upstream. Complex products can be tested as a finished product since DNA will still be present – it can be damaged by heat and acidity, but on the whole it’s fairly robust, and it can withstand great external forces.”
GMO-free or Non-GMO?
In a recent guidance document, the FDA addresses 'GMO-free,' 'GE-free,' 'does not contain GMOs,' 'non-GMO' and similar claims.
"The term 'free' conveys zero or total absence unless a regulatory definition has been put in place in a specific situation (Refs. 14, 15). The potential challenges of substantiating a 'free' claim are described in Section III.D of this guidance, and in light of these challenges FDA recommends that manufacturers not use food labeling claims that indicate that a food is 'free' of ingredients derived through the use of biotechnology. Instead, FDA recommends that manufacturers consider the use of other types of statements to indicate that a plant-derived food has not been produced using bioengineering [such as:
- Not bioengineered
- Not genetically engineered
- Not genetically modified through the use of modern biotechnology
- We do not use ingredients that were produced using modern biotechnology
- This oil is made from soybeans that were not genetically engineered
- Our corn growers do not plant bioengineered seeds].
However, Justin Prochnow, shareholder at law firm Greenberg Traurig, noted that labeling legislation doesn't define GMO-free or non-GMO, adding:
"I don't really see a distinction between the ['GMO-free' and 'Non-GMO'] claims. First of all, most of the GMO labeling regulations to date don't address 'non-GMO' or 'GMO-Free' claims; instead, they impose requirements for including representations of genetically engineered material when present.
"In other situations, 'No' means the same as 'Free,' such as 'No Sugar' or 'Sugar Free' or 'No Cholesterol' or 'Cholesterol Free.' In those situations, you are allowed to have less than .5g of a substance and still say it is "_____ free" or "No ________". So, there is no distinction there."
The FDA guidance above, meanwhile, just highlights that the FDA would prefer it if firms didn't use the terms non-GMO OR GMO-free, he said, but instead used one of the terms in the bulleted list above.
Can NGS tests identify foods developed using gene-editing tools such as CRIPSR-cas9?
And what about foods developed using new ‘gene-editing’ techniques such as CRISPR-cas9 – described by some as like using a ‘molecular scalpel’ to make precise changes in the DNA and cells of organisms without introducing genes from unrelated species? Can Clear Labs’ test pick these up?
“Our screens cover all known GMOs,” said Ghorashi. “However, it’s important to note that CRISPR is going to pose a challenge as it doesn’t leave scars in the genome that are easily detectable via methods like ours.
“We're going to have to move into whole-genome sequencing to combat that, but it's a few years down the line before we need to worry for the broader food supply chain.”
Genetically engineered processing aids – ingredients used in the production of a food or food ingredient that are not necessarily present in the final product – are also on Clear Label’s radar, although lawmakers do not typically consider foods made with these to require GE labeling.
(The federal GMO labeling law does not specifically mention processing aids, but stricter standards such as the Non-GMO Project do take them into account when deciding if a product can be considered non-GMO.)
“In the V2 version of our next GMO test, we’re introducing methods to screen for things that are indirectly used in the process,” said Ghorashi. “But in the first iteration, we’re looking at the [end] product primarily.”
‘GMO labeling legislation aside, we’re seeing a trend of more transparency … and this means more testing.’
So what kind of feedback has Clear Labs had from the food and beverage industry, and are companies confused about what testing they need to do, and what the new federal law will require?
According to Ghorashi: “The Vermont bill [which has been superseded by the federal bill just signed by President Obama] threw a lot of brands into a conundrum, because they saw the consumer demand and they want to hedge against what’s coming.
“But [GMO labeling] bills aside, we’re seeing a trend of more transparency rather than less transparency, and this means more testing, and the more forward-thinking brands are eager to verify GMO-free ahead of the curve.
“We’ve seen great interest from large brands on both tests. We also have a product called Clear View, which aggregates the results from all their testing data and merges it with other data to have an analytics-based view for our customers so they can identify vulnerabilities in their supply chain and see the big picture.
“We’re piloting this with some large multinational food companies that are sourcing ingredients from all over the world.”
We'd love to work with the Non-GMO Project
So is Clear Labs competing with the Non-GMO Project?
No, says Ghorashi: “They do amazing work and cover supply chain factors that we don’t touch, so we certainly hope that we might be able to partner with them in some capacity to offer our NGS test as a solution to their industry customers. We are complementary.”
This is a fudge and Misleading to the Public
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